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Federal Register notice: FDA seeks comments on an information collection extension entitled Generic Drug User Fee Program.[ Price : $8.95]
Heron submits an NDA for its HTX-019 injectable emulsion to prevent postoperative nausea and vomiting in adults.[ Price : $8.95]
FDA clears a Lunit 510(k) for its Insight MMG, an artificial intelligence application for breast cancer detection.[ Price : $8.95]
FDA says it is working with Medtronic to evaluate outcomes after cardiac perforation following implantation of leadless pacemaker ...[ Price : $8.95]
FDA approves a new renal cell carcinoma indication for Mercks Keytruda.[ Price : $8.95]
FDA says its Division of Drug Information pharmacists are available to answer consumer questions about taking drugs.[ Price : $8.95]
FDA updates possible mitigation strategies to reduce the risk of nitrosamine drug substance-related impurities in drug products.[ Price : $8.95]
FDA tells a Texas federal court it needs until 2076 to respond to a Public Health and Medical Professionals for Transparency reque...